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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study performed on July 30 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
determination of fibre length and diameter distributions
Type of distribution:
counted distribution
Percentile:
D50
Mean:
ca. 512.4 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
ca. 254.4 µm
Remarks on result:
other: No st. deviation reported
Percentile:
D50
Mean:
ca. 512.4 µm
Remarks on result:
other: No st. deviation reported
Percentile:
D90
Mean:
ca. 923.6 µm
Remarks on result:
other: No st. deviation reported
Conclusions:
The study concludes that ca. 10% of particles have a particle size of <254.4 µm and is therefore not considered to present an inhalation risk. This study is considered to be scientifically justified for use as a key study.

Description of key information

One key study exists. This study (Fieseler A, 2009) was conclusive, done to a valid guideline (OECD TG 110) and the study was conducted under GLP conditions. It is therefore scientifically justified for use as a key study under Regulation (EC) No. 1907/2006.

Additional information

The study concludes that ca. 10% of particles have a particle size of <254.4 µm and is therefore not considered to present an inhalation risk. This study is considered to be scientifically justified for use as a key study.